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Quality and Regulatory

Understanding FDA Complete Response Letters

Justin Johnson, PDA

Building Maturity and Resilience Through Quality Culture

Annette Boland, PharmaLex

PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience

Walter Morris, PDA

News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA

From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis

Anya Hillery, PhD, Freelance Medical Writer

The New Normal at the FDA

Katie Bevard, Eli Lilly

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta, Pharmalex

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

Walter Morris, PDA

News Brief: FDA Announced FDA Precheck

Justin Johnson, PDA

News Brief: PDA AI Glossary Now Available

Walter Morris, PDA

News Brief: U.S. FDA Head Makary Says Severity of FDA Layoff Overstated

Walter Morris, PDA

News Brief: Sean Keveney Appointed Chief Counsel of FDA

Justin Johnson, PDA

News Brief: FDA Appoints Dr. George Tidmarsh as Director of CDER

Walter Morris, PDA

News Brief: FDA Releases 200 Drug Rejection Letters

Justin Johnson, PDA

Planning for a Dual-Method Future

Nora Blair, Charles River

News Brief: FDA Finalizes Guidance on Remote Regulatory Assessments

Justin Johnson, PDA

News Brief: FDA Issues Draft ICH Stability Guideline for Public Comment

Walter Morris, PDA

Leading the Turnaround

Troy Chavis, PrecisionPharma Manufacturing Solutions, LLC

Effective AI Deployment in Drug Manufacturing

Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

Leadership, Layoffs, and Legislation

Katie Bevard, Eli Lilly

News Brief: U.S. FDA Launches AI Tool, Elsa

Justin Johnson, PDA

News Brief: AI and Reshoring Topic of One-Day DC Event

Walt Morris, PDA

PDA Europe and EMA Unite

Toni Manzano, PhD, Aizon

News Brief: Successful AI Pilot Prompts FDA to Launch Full-Scale Integration

Justin Johnson, PDA

News Brief: U.S. FDA Announces Limits to Industry Employees Serving on FDA Advisory Committees

Walter Morris, PDA

Bioburden Monitoring for Primary-Packaging Sterile Manufacturing

Bart Moens, Organon

Understanding the UK’s International Recognition Procedure

Claire Stevenson, PhD, PharmaLex and Aashni Shah, PharmaLex

Global Regulatory Convergence — What If?

Glenn Wright

Knowledge Management and its Relation to Data Integrity

Kristen Anderson, PhD , Klaus Finneiser , Kir Henrici, The Henrici Group , Megan Powdrill , and James L. Vesper, PhD, PDA Knowledge Management Roadmap Team